The EIR was issued following an inspection of the facility conducted from 10 June to 13 June 2024.
Nilesh Gupta, Managing Director, Lupin, said, “We are very pleased to have received the EIR from the US FDA for drug-device combination products at our Nagpur injectable facility. We remain committed to producing complex generic and essential products that address unmet needs."
Mumbai-based Lupin is an innovation-led, transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
Lupin’s consolidated net profit jumped 38.81% to Rs 858.86 crore on a 10.60% increase in sales to Rs 5,618.6 crore in Q3 FY25 compared to Q3 FY24.
Shares of Lupin rose 0.51% to Rs 1,945.65 on the BSE.